Evidence map›Paper›PMID 33331042›Full record

ArticleJournal of thrombosis and haemostasis : JTH2021

Establishment of a framework for assessing mortality in persons with congenital hemophilia A and its application to an adverse event reporting database.

Steven W Pipe, Rebecca Kruse-Jarres, Johnny N Mahlangu, Glenn F Pierce, Flora Peyvandi, Peter Kuebler, Christian De Ford, Fabián Sanabria, Richard H Ko, Tiffany Chang and 1 more

Abstract readCase Reports
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of thrombosis and haemostasis : JTH, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Emicizumab state-of-the-art update.Haemophilia : the official journal of the World Federation of Hemophilia · 2022
    Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Steven W PipeDepartments of Pediatrics and Pathology, University of Michigan Medical School, Ann Arbor, MI, USA.ORCID 0000-0003-2558-2089
Rebecca Kruse-JarresUniversity of Washington, Seattle, WA, USA.
Johnny N MahlanguUniversity of the Witwatersrand and NHLS, Johannesburg, South Africa.
Glenn F PierceWorld Federation of Hemophilia, Montreal, QC, Canada.
Flora PeyvandiIRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.
Peter KueblerGenentech, Inc., South San Francisco, CA, USA.
Christian De FordF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Fabián SanabriaF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Richard H KoGenentech, Inc., South San Francisco, CA, USA.
Tiffany ChangGenentech, Inc., South San Francisco, CA, USA.
Charles R M HayUniversity of Manchester, Manchester, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite recent therapeutic advances, life expectancy in persons with congenital hemophilia A (PwcHA) remains below that of the non-HA population. As new therapies are introduced, a uniform approach to the assessment of mortality is required for comprehensive evaluation of risk-benefit profiles, timely identification of emerging safety signals, and comparisons between treatments.

objectivesDevelop and test a framework for consistent reporting and analysis of mortality across past, current, and future therapies. PATIENTS/

methodsWe identified known causes of mortality in PwcHA through literature review, analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, and expert insights. Leading causes of death in general populations are those recognized by the Centers for Disease Control and Prevention and the World Health Organization. We developed an algorithm for assessing fatalities in PwcHA and used this to categorize FAERS data as a proof of concept.

resultsPwcHA share mortality causes with the non-HA population including cardiovascular disease, malignancy, infections, pulmonary disease, dementias, and trauma/suicide. Causes associated with HA include hemorrhage, thrombosis, human immunodeficiency virus, hepatitis C virus, and liver dysfunction. We propose an algorithm employing these classes to categorize fatalities and use it to classify FAERS fatality data between 01/01/2000 and 03/31/2020; the most common causes were hemorrhage (22.2%) and thrombosis (10.4%).

conclusionsA conceptual framework for examining mortality in PwcHA receiving any hemophilia therapy is proposed to analyze and interpret fatalities, enabling consistent and objective assessment. Application of the framework using FAERS data suggests a generally consistent pattern of reported mortality across HA treatments, supporting the utility of this unified approach.

Indexed as

Adverse Drug Reaction Reporting SystemsCause of DeathComorbidityDatabases, FactualFemaleHemophilia AHumansLife ExpectancyMaleUnited Statesalgorithmscause of deathdata analysishemophilia Amortality

Identifiers

PMID33331042
PMCPMC7756842

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.